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May 9, 2011 

 

CENTER FOR VETERINARY BIOLOGICS NOTICE NO. 11-12 

TO: Biologics Licensees, Permittees, and Applicants 

Directors, Center for Veterinary Biologics 

 Veterinary Services Management Team 

 

FROM: Richard E. Hill, Jr. /s/ Richard E. Hill, Jr. 

Director 

 Center for Veterinary Biologics 

SUBJECT: Product Licensing Plans 

I. PURPOSE 

The purpose of this notice is to announce the availability of Product Licensing Plans for 

biological products in the pre-approval stage of regulatory review. 

II. BACKGROUND 

Based on industry best practices, biological manufacturers and importers often create 

product development plans, with set procedures and goals for achieving regulatory 

approval. In the past, the Center for Veterinary Biologics (CVB) provided comment on 

these plans if they were submitted for review. To provide additional assistance to 

industry, the CVB will begin making available standardized, comprehensive regulatory 

plans for each product proposed for a Biological Product License or a Permit for 

Distribution and Sale. 

III. POLICY 

As early in the licensing/permitting process as possible, the assigned CVB Reviewer 

works with the applicant to identify requirements to approve a specific product. 

Minimum information necessary to initiate the Product Licensing Plan includes: 

 Draft Outline of Production or equivalent manufacturing and testing information 

 Proposed product claims and recommendations for use 

 Relationships to existing approved products, if any 

The applicant has the opportunity to discuss specific approaches to fulfill each of the 

requirements and may enter into Critical Path Agreements with the CVB, as desired. A 

Critical Path Agreement provides formal documentation of an agreement in principle

regarding the study design or approach needed to fulfill a regulatory requirement. It 

United States 

Department of 

Agriculture

Animal and Plant 

Health Inspection 

Service 

Veterinary Services 

Center for Veterinary 

Biologics 

1920 Dayton Avenue 

PO Box 844 

Ames, IA 50010 

(515) 337-6100 
CENTER FOR VETERINARY BIOLOGICS NOTICE NO. 11-12 

Page 2 

represents a commitment that the CVB will not later alter perspectives on this issue for 

this particular product unless a product quality or animal health concern appears that the 

CVB did not recognize at the time the issue was assessed. It is not a guarantee of 

acceptance of all possible study outcomes. 

The Product Licensing Plan, maintained in a standardized spreadsheet format, itemizes 

all required protocols, studies, data, and documentation. The spreadsheet is updated as 

those items are submitted and reviewed by the CVB, so that it reflects real-time status 

toward product approval. Although the Plan is intended to be as complete as possible 

from the beginning, the spreadsheet is a living document and may be amended if repeat 

studies or addenda become necessary. 

Applicants may request a copy of their Product Licensing Plan at any time by contacting 

their CVB Reviewer. 

IV. IMPLEMENTATION/ APPLICABILITY 

This policy is effective for all products, domestically manufactured or imported, for 

which applications are received from this time forward. Applicants also may request a 

Product Licensing Plan for any product currently in the pre-approval stage of review. 

Product Licensing Plans are intended to be interactive between the CVB and the 

applicant, but the applicant may decide upon the degree of involvement to take in plan 

development. Applicants are not required to submit their own development plans or any 

other related documentation that they have not historically provided, but the CVB 

welcomes the submission of information that will facilitate the compilation of a complete 

and meaningful Product Licensing Plan.